COMPEED PSORIASIS DRESSING

K982493 · Coloplast Corp. · FRO · Jan 28, 1999 · SU

Device Facts

• Record ID: K982493
• Device Name: COMPEED PSORIASIS DRESSING
• Applicant: Coloplast Corp.
• Product Code: FRO · SU
• Decision Date: Jan 28, 1999
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Compeed® Psoriasis Dressing is indicated for use in the management of psoriasis and protection of psoriatic plaques.

Device Story

Compeed® Psoriasis Dressing is a non-sterile, hydrocolloid skin protector designed for management of chronic plaque-type psoriasis. Device consists of a polyurethane film backing with a hydrocolloid adhesive layer composed of carboxymethylcellulose, petroleum hydrocarbon resin, copolymer, and dioctyl adipate. Applied topically to knees and elbows to protect psoriatic plaques. Intended for over-the-counter use. Device acts as a physical barrier; does not accelerate wound healing or treat/cure psoriasis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Hydrocolloid dressing. Materials: Carboxymethylcellulose, petroleum hydrocarbon resin, copolymer, dioctyl adipate, polyurethane film. Form factor: Triangular, single-size adhesive patch. Non-sterile. Standalone device.

Indications for Use

Indicated for management of psoriasis and protection of psoriatic plaques on knees and elbows.

Predicate Devices

• Compeed® Athletic Dressing (K883588)

Submission Summary (Full Text)

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JAN 28 1999

## 510(k) Summary Compeed® Psoriasis Dressing

Coloplast Corporation 1955 West Oak Circle Marietta, Georgia 30062-2249 Date: 1/20/99

## 1. Contact Person

Ms. Sydney Lilly, [phone]

## 2. Name of the Medical Device

Classification name:

Common/usual name: PROPRIETARY name:

General Hospital and Personal Use Therapeutic Devices Skinprotector Compead® Psoriasis Dressing

## 3. Device Classification

Unclassified

#### 4. Statement of Substantial Equivalence

The Compeed® Psoriasis Dressing is identical to the Compeed® Athletic Dressing manufactured by Coloplast A/S and approved for market under 510(k) K883588.

## 5. Intended Use

The Compeed® Psoriasis Dressing is indicated for use in the management of psoriasis and protection of psoriatic plaques.

#### 6. Description of Device

The Compeed® Psoriasis Dressing is a non-sterile, hydrocolloid dressing marketed in Europe for the management of chronic plaque-type Psoriasis.

A comparison Matrix for the Compeed® Psoriasis Dressing versus the Compeed® Athletic Dressing is presented in Table 1.

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# 510(k) Summary Compeed® Psoriasis Dressing - Table 1 Comparison to Legally Marketed Device

| | Compeed® Psoriasis<br>Dressing | Compeed® Athletic<br>Dressing K883588 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Device<br>composition | Carboxymethylcellulose,<br>Petroleum hydrocarbon<br>resin, compolymer,<br>Dioctyl adipate,<br>Polyurethane film, silicone paper | Carboxymethylcellulose,<br>Petroleum hydrocarbon<br>resin, compolymer,<br>Dioctyl adipate,<br>Polyurethane film, silicone paper |
| Shape | triangular | oval |
| Sizes | one size | small, medium, large |
| Location of<br>device | Knees and elbows | Foot |
| Function of<br>device | Skinprotector | Skinprotector |
| Indication for use | Non-sterile skin protector<br>for use on chronic<br>plague-like psoriasis | Non-sterile, skin protector<br>to prevent blisters and<br>protect skin from friction<br>that leads to calluses and<br>corns |
| Sterilization | Non-sterile | Non-sterile |
| Packaging | Hard plastic casing | Hard plastic casing |

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 28 1999

Ms. M. Sydney Lilly Coloplast Corporation 1955 West Oak Circle Marietta, Georgia 30062

Re: K982493 Trade Name: Compeed Psoriasis Dressing Regulatory Class: Unclassifed Product Code: MGP Dated: October 29, 1998 Received: November 2, 1998

Dear Ms. Lilly:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

- 1. This device may not be labeled for use on third degree burns.
- This device may not be labeled as having any accelerating effect on the rate of 2. wound healing or epithelization.
- 3. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
- This device may not be labeled as a treatment or a cure for any type of wound. 4.

The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).

The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

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Page 2 - Ms. Sydney Lilly

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or 301-443-6597 or at its internet address http://www.fda.gov/cdrb/dsmamain.html.

Sincerely yours,

-Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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493 510(k) Number (if known):

Device Name: Compeed® Psoriasis Dressing

Indications for Use:

The Compeed® Psoriasis Dressing is indicated for use in the management of psoriasis and protection of psoriatic plaques.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division S al Restorative I

Prescription Use (Per 21 CFR 801.109 ાર

Over-The-Counter Use √

(Optional Format 1-2-96)